Quali-Med's Operating Room Drapes
by Quali-Med, Inc. 510(k)
Active
510(k) K862172
Overview
The Quali-Med Operating Room Drape is a surgical drape designed for use in operating rooms to maintain a sterile field during surgical procedures. These drapes are intended to isolate the surgical site from contamination, providing a barrier between the patient and the surrounding environment. Constructed from plastic materials, they are part of the standard operating room setup to ensure aseptic conditions. The device falls under the category of surgical drapes, adhering to regulatory standards for medical textiles in surgical settings.
These drapes are supplied as single-use items and are intended for reusable application in controlled surgical environments. They are classified under product code KKX and have been cleared by the FDA through a 510(k) submission (K862172) as substantially equivalent to a predicate device. The drapes are not intended for MRI use and must be stored in a clean, dry environment to preserve sterility and integrity. No additional regulatory markings or certifications beyond the FDA clearance are referenced in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK862172 | Date19 Jun 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KKX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4370
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Quali-Med, Inc.
Questions
What is the Quali-Med Operating Room Drape used for?
The Quali-Med Operating Room Drape is designed to create and maintain a sterile barrier during surgical procedures. It isolates the surgical site from contamination, protecting both the patient and the environment by preventing airborne particles, microorganisms, and fluids from reaching the sterile field. This is critical in operating rooms to reduce infection risks and ensure aseptic conditions.
Are these drapes single-use or reusable?
The Quali-Med Operating Room Drape is intended for single-use applications. While it is classified under product code KKX, which can include reusable items, the manufacturer specifies it is meant for one-time use in controlled surgical environments. This ensures sterility and reduces the risk of cross-contamination between patients.
How should these drapes be stored to maintain sterility?
To preserve sterility and structural integrity, these drapes must be stored in a clean, dry environment away from direct sunlight, moisture, or chemical fumes. Proper storage prevents degradation of the plastic material and contamination, ensuring the drape remains effective when needed for surgical procedures.
Can these drapes be used in MRI environments?
No, the Quali-Med Operating Room Drape is explicitly not intended for use in MRI environments. The plastic material and design are optimized for standard surgical settings, not for compatibility with magnetic resonance imaging equipment, which requires non-ferromagnetic materials.
What regulatory approval does this drape hold?
The Quali-Med Operating Room Drape has been cleared by the FDA through a 510(k) submission (K862172), demonstrating it is substantially equivalent to a predicate device. This clearance confirms it meets regulatory standards for surgical drapes under product code KKX, ensuring its safety and effectiveness for use in operating rooms.